(1)

Pursuant to Regulation (EC) No 1924/2006, health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in the Union list of permitted health claims.

(2)

Regulation (EC) No 1924/2006 also provides that applications for authorisation of health claims may be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid applications to the European Food Safety Authority (‘the Authority’).

(3)

Following the receipt of an application, the Authority is to inform without delay the other Member States and the Commission, and to deliver an opinion on the health claim concerned.

(4)

The Commission is to decide on the authorisation of the health claim taking into account the opinion delivered by the Authority.

(5)

Following an application from Nestlé S.A., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related to beta-glucans sourced from oats and/or barley in ready-to-eat breakfast cereals manufactured via pressure cooking and to the reduction of blood glucose rise after consumption (Question No EFSA-Q-2020-000447). The claim proposed by the applicant was worded as follows: ‘Consumption of beta-glucans from oats and/or barley in a ready-to-eat breakfast cereal contributes to a reduction of the blood glucose rise after that meal’.

(6)

On 8 April 2021, the Commission and the Member States received the scientific opinion (2) on that claim from the Authority, which concluded that, on the basis of the data presented, the effect of beta-glucans in reducing post-prandial blood glucose responses is well established. However, the evidence provided had been insufficient to establish an effect on reduction of post-prandial glycaemic responses at doses of 1,3 g beta-glucans per 25 g of available carbohydrate incorporated into ready-to-eat breakfast cereals manufactured by pressure cooking (i.e. either batch cooking or extrusion), as requested by the applicant. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted health claims, it should not be authorised.

(7)

Following an application from Pharmactive Biotech Products, S.L., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related to Affron® and the contribution to the maintenance of a healthy mood (Question No EFSA-Q-2020-00617). The claim proposed by the applicant was worded as follows: ‘Affron® contributes to maintain a healthy mood by reducing the negative traits of depressive and anxiety feelings’.

(8)

On 6 July 2021, the Commission and the Member States received the scientific opinion (3) on that claim from the Authority, which concluded that, on the basis of the data presented, the evidence provided had been insufficient to establish a cause and effect relationship between the consumption of Affron® and increase in positive mood. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted health claims, it should not be authorised.

(9)

Following an application from Praline i Cokolada j.d.o.o., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related to MegaNatural®-BP grape seed extract and the maintenance of normal blood pressure (Question No EFSA-Q-2020-00718). The claim proposed by the applicant was worded as follows: ‘MegaNatural®-BP helps maintain healthy blood pressure’.

(10)

On 9 August 2021, the Commission and the Member States received the scientific opinion (4) on that claim from the Authority, which concluded that, on the basis of the data presented, the evidence provided had been insufficient to establish a cause and effect relationship between the consumption of MegaNatural®-BP, a grape seed extract standardised for total phenolics, gallic acid and the sum of catechin and epicatechin content, and maintenance of normal blood pressure. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted health claims, it should not be authorised.

(11)

Following an application from Sensus B.V. (Royal Cosun), submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related to Frutalose® and the maintenance of normal defecation (Question No EFSA-Q-2020-00631). The claim proposed by the applicant was worded as follows: ‘Frutalose® chicory oligofructose contributes to regular bowel function by increasing stool frequency’. The applicant also provided three alternative wordings for the claim.

(12)

On 12 August 2021, the Commission and the Member States received the scientific opinion (5) on that claim from the Authority, which concluded that, on the basis of the data presented, the evidence provided was insufficient to establish a cause and effect relationship between the consumption of Frutalose® and the maintenance of normal defecation under the proposed conditions of use. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted health claims, it should not be authorised.

(13)

The comments by Nestlé S.A. on the Authority’s opinion on the health claim relating to beta-glucans sourced from oats and/or barley in ready-to-eat breakfast cereals manufactured via pressure cooking and to the reduction of blood glucose rise after consumption (Question No EFSA-Q-2020-000447), received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006, have been considered when adopting this Regulation.

(14)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Commission Implementing Regulation (EU) 2020/761 (2) lays down the rules for the management of import and export tariff quotas for agricultural products managed by a system of import and export licences and provides for specific rules.

(2)

Commission Implementing Regulation (EU) 2020/1988 (3) lays down the rules for the administration of import tariff quotas designed to be used following the chronological order of dates of acceptance of customs declarations (‘first come, first served’ principle).

(3)

The Agreement between the European Union and the United States of America pursuant to Article XXVIII of the General Agreement on Tariffs and Trade (GATT) 1994 relating to the modification of concessions on all the tariff rate quotas included in the EU Schedule CLXXV as a consequence of the United Kingdom`s withdrawal from the European Union, concluded by Council Decision (EU) 2023/912 (4), amends the quantities of products to be imported under some tariff quotas opened in favour of the United States and some tariff quotas opened for all other countries. The tariff quotas with following order numbers are concerned: 09.0035, 09.0040, 09.0041, 09.0055, 09.0056, 09.0059, 09.0070, 09.0073, 09.0083, 09.0089, 09.0093, 09.0094, 09.0123, 09.0147, 09.4002, 09.4038, 09.4116, 09.4123, 09.4127 and 09.4170.

(4)

The amendments made by that Agreement should be reflected in Annexes to Implementing Regulations (EU) 2020/761 and (EU) 2020/1988.

(5)

Implementing Regulations (EU) 2020/761 and (EU) 2020/1988 should therefore be amended accordingly.

(6)

Transitional provisions are needed to clarify how to handle the situations that may arise as a result of the amendments of quantities of products to be imported under the tariff quotas concerned. This concerns tariff quotas that are managed in periods divided into sub-periods. It also concerns tariff quotas that are managed in accordance with the first come, first served principle, where the amendment of quantities leads to either an increase of the quantity of a tariff quota that was exhausted or to a decrease of the available quantity of a tariff quota for products that were already released for free circulation in the Union.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of Agricultural Markets,

(1)

On 24 April 2019, AS Chemi-Pharm submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for authorisation of the same single biocidal product, as referred to in Article 1 of that Regulation, named ‘Chemisept IPA-N’, of product-type 1, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-UU051173-14 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference biocidal product family ‘Knieler & Team Propanol Family’, recorded in the Register under case number BC-AQ050985-22.

(2)

The same single biocidal product ‘Chemisept IPA-N’ contains propan-1-ol and propan-2-ol as the active substances, which are included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 1.

(3)

On 8 December 2021, the Agency submitted to the Commission an opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Chemisept IPA-N’ in accordance with Article 6 of Implementing Regulation (EU) No 414/2013.

(4)

The opinion concludes that the proposed differences between the same single biocidal product and the related reference biocidal product are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (4), and that based on the assessment of the related reference biocidal product family ‘Knieler & Team Propanol Family’ and subject to compliance with the draft SPC, the same single biocidal product meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.

(5)

On 24 October 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(6)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same single biocidal product ‘Chemisept IPA-N’.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

(1)

On 24 April 2019, Chemi-Pharm AS submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for Union authorisation of the same single biocidal product, as referred to in Article 1 of that Regulation, named ‘Bacticid IPA-N’, of product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-SM051156-28 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference biocidal product family ‘Knieler & Team Propanol Family’, recorded in the Register under case number BC-AQ050985-22.

(2)

The same single biocidal product ‘Bacticid IPA-N’ contains propan-1-ol and propan-2-ol as the active substances, which are included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 4.

(3)

On 8 December 2021, the Agency submitted to the Commission an opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Bacticid IPA-N’ in accordance with Article 6 of Implementing Regulation (EU) No 414/2013.

(4)

The opinion concludes that the proposed differences between the same single biocidal product and the related reference biocidal product are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (4), and that based on the assessment of the related reference biocidal product family ‘Knieler & Team Propanol Family’ and subject to compliance with the draft SPC, the same single biocidal product meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.

(5)

On 24 October 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(6)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same single biocidal product ‘Bacticid IPA-N’.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

(1)

Commission Implementing Decision (EU) 2022/2333 (2) was adopted within the framework of Regulation (EU) 2016/429, and it lays down emergency measures relating to outbreaks of sheep pox and goat pox in Spain, that were detected in the regions of Andalusia and Castilla-La Mancha, where they form two distinct clusters, one in each region. That Implementing Decision applies until 31 October 2023.

(2)

More particularly, Implementing Decision (EU) 2022/2333 provides that the protection, surveillance and further restricted zones, to be established by Spain following outbreaks of sheep pox and goat pox, in accordance with Article 21 of Commission Delegated Regulation (EU) 2020/687 (3), are to comprise at least the areas listed in the Annex to that Implementing Decision.

(3)

In addition to the protection and surveillance zones, a further restricted zone was established, in accordance with Article 21(1), point (c), of Delegated Regulation (EU) 2020/687, in both the regions of Andalusia and Castilla-La Mancha, where Spain is required to apply certain measures regarding restrictions on the movements of sheep and goats outside that further restricted zone, with a view to preventing the spread of sheep pox and goat pox to the rest of its territory and to the rest of the Union.

(4)

After the adoption of Implementing Decision (EU) 2022/2333, Spain notified the Commission of a number of additional outbreaks of sheep pox and goat pox in establishments where sheep and/or goats were kept. As a result, the areas listed as protection and surveillance zones, as well as the areas listed as further restricted zones for Spain, in the Annex to Implementing Decision (EU) 2022/2333, were subsequently amended. The last amendment to that Annex was made by the Commission Implementing Decision 2023/872 (4).

(5)

Since the date of adoption of Implementing Decision (EU) 2023/872, Spain has notified the Commission of one additional outbreak of sheep pox and goat pox in establishments where sheep and/or goats were kept, in the region of Castilla-La Mancha, more specifically in the Province of Cuenca, outside the surveillance zone already established in that region.

(6)

The competent authority of Spain has taken the necessary disease control measures required in accordance with Delegated Regulation (EU) 2020/687, including the establishment of protection and surveillance zones around the new outbreak. Spain has also maintained the previously established restricted zones, around the previous outbreaks, recorded since the beginning of 2023 in Castilla-La Mancha, in the Province of Ciudad Real.

(7)

Therefore, the areas listed as protection, surveillance and further restricted zones for Spain in the Annex to Implementing Decision (EU) 2022/2333 should be amended, spatially and temporally, taking into account the current epidemiological situation as regards sheep pox and goat pox in the region of Castilla-La Mancha.

(8)

Given the urgency of the epidemiological situation in the Union as regards the spread of sheep pox and goat pox, it is important that the amendments to be made to the Annex to Implementing Decision (EU) 2022/2333 by this Decision take effect as soon as possible.

(9)

In addition, taking into account the current epidemiological situation in the Union as regards sheep pox and goat pox, the period of application of Implementing Decision (EU) 2022/2333 should be prolonged until 31 December 2023.

(10)

Implementing Decision (EU) 2022/2333 should therefore be amended accordingly.

(11)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Pursuant to Article 7(3)(d) of the Agreement between the European Community and the United States of America on the mutual recognition of certificates of conformity for marine equipment (‘the Agreement’), the Joint Committee established under Article 7(1) of the Agreement may amend the Annexes thereto.

(2)

In order to support the proper implementation of the legislation that is within the scope of the Agreement it is important to include interpretations developed by the notified body coordination group established under Directive 2014/90/EU of the European Parliament and of the Council (1) as well as policy guidance issued by the U.S. Coast Guard in the list of laws, regulations and administrative provisions listed in Annex I.

(3)

Therefore, Annex I to the Agreement should be amended accordingly.

(4)

In accordance with Article 7(3)(a) of the Agreement, the Joint Committee is responsible for developing and maintaining the list in Annex II of products and associated legislative, regulatory and administrative provisions that the Parties have determined to be equivalent.

(5)

Taking into account technical progress and changes to the international instruments, the European Union and the United States of America have agreed on the modification of the product coverage for mutual recognition.

(6)

Therefore, Annex II of the Agreement should be amended accordingly.

(7)

The list of regulatory authorities and their addresses should be updated and the regulatory authority of the United Kingdom should be removed.

(8)

Therefore, Annex III of the Agreement should be amended accordingly,